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Ridge Diagnostics |
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October 28, 2013 Issue |
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The Most Powerful Name In Corporate News and Information |
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Proprietary First-in-Class Blood Test for Major Depressive Disorder (MDD) |
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Ridge Diagnostics
is a neurodiagnostic company offering its proprietary first-in-class blood
test for Major Depressive Disorder (MDD) through its CLIA certified
laboratory in North Carolina. Based upon its proprietary Human Biomarker
Library and its Biomarker Hyper-Map™ technology platform, Ridge Diagnostics
researches, develops, and commercializes multi-variant biological marker
assays and diagnostic algorithms to diagnose, select and monitor treatment
for Major Depressive Disorder and other neuropsychiatric disorders. Lonna J. Williams, CEO of Ridge Diagnostics, has over 25 years of experience in executive management and commercial operations in medical diagnostics and devices. Lonna has successfully brought 26 new products to market, commercializing four novel technologies, and integrating diagnostics and pharmaceuticals for personalized medicine applications. She has held senior management positions in large, multinational companies and start-up organizations including Johnson and Johnson, Hybritech Inc. /Eli Lilly and Co., Gen-Probe Inc., Quidel Corp., Prometheus Inc. and Viking Systems. Lonna founded two companies prior to joining Ridge in 2008 and in 2009 became Ridge’s CEO.
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Neurodiagnostics
Ridge Diagnostics 4225 Executive Square, Suite 600 La Jolla, CA 92037
800-578-7818
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CEOCFO Magazine,
Published – October 28, 2013
Ms. Williams: What initially attracted me to Ridge Diagnostics was the opportunity to explore an entirely new blood test having the potential to change the lives of many people suffering from mental disorders. I originally became involved with the company as an outside consultant. When I was introduced to Ridge Diagnostics they hired me to assess whether or not a blood test for depression would be of interest to the market. Frankly, I did not know. However, it sounded intriguing so my team and I performed a significant amount of primary market research. We spoke with physicians all over the country and in various specialties. The response was overwhelming; from “We absolutely need something like this test” which we heard from primary care physicians to psychiatrists saying, “A depression blood test, that is fascinating. It has never been done before. It would be very helpful to us and our patients. Can you really do it?” At that time the company had proof of principal in early research. Once we reported and documented these findings Ridge decided to proceed with implementing a clinical study on the diagnostic. It was shortly after that I established an overall business and financing plan for Ridge; again as an outside consultant. When the board decided to hire a CEO that had experience in the diagnostic industry they asked me to take on the role which I did. I have been Ridge’s CEO since 2009.
CEOCFO: Where does the concept stand today? Ms. Williams: The concept is actually now a reality and available. The first blood test for aiding in the diagnosis of Major Depressive Disorder is on the market. The test is branded MDDScore™. Ridge Diagnostics began to sell MDDScore to psychiatrists in various states in the country this past spring.
CEOCFO: How does the test work? What is the science? Ms. Williams: Ridge starts with a simple blood draw and we look for biomarkers. We are looking for specific proteins, hormones and enzymes, representing four physiological pathways, that our scientists know respond predictably when a patient is suffering from Major Depressive Disorder. We evaluate nine different biomarkers; put them through a proprietary algorithmic model and the result is a single test score. If the test score is a five to nine it means that there is a ninety percent likelihood that the patient is suffering from Major Depressive Disorder. If the score is four or less then there is a ninety-five percent likelihood that the patient is not suffering from Major Depressive Disorder. The nine biomarkers are identified in the blood stream which in the case of mental health is highly unusual. It is really one of the few practical ways to assess this condition. Ridge provides the first objective diagnostic information in any area of mental health from a blood test. That makes it truly ground breaking.
CEOCFO: Do the different items that you are looking at carry a different weight? Would you tell us about the nuances in how you figure it out? Ms. Williams: The different biomarkers were included for a couple of reasons. One; some of them are proteins whose levels are responses to genetic information. Others are triggered by the state that the person is in at that time. Both work together to create a meaningful diagnostic test. The markers are weighted in the algorithm differently; however, they all contribute in a unique way. In a recent clinical study, which was completed at the beginning of 2013, and prior to our commercialization, Ridge added gender and body mass index to the algorithm as additional variables. We found that those two elements play a role in MDD. That was a new finding and something that we were very pleased to add and has enhanced the overall performance of the test.
CEOCFO: Was it not known what to look for? Was it not being able to write an algorithm? What have you figured out that others have not been able to do? Ms. Williams: It was really the application of something that was known, but had never been taken forward the way Ridge has done. This understanding, not the test as it exists today, but the early understanding, of how these available and detectable proteins, hormones and enzymes could contribute to a diagnostic was learned by two of our scientists, and our academic research partners, from their experience in translational medicine, an area of pharmaceutical research which identifies biomarker patterns that aid in characterizing patient conditions and their potential response to research drugs. In this case they were working in the area of mental health, antidepressants and other related drug classes. They started to think about it and thought," Why not apply biomarkers to identify patients who are suffering from neuropsychiatric disorders". Their idea was to start a company that would focus on biomarkers to use for diagnostic purposes. In 2006 Ridge was founded.
CEOCFO: What has been the reception thus far? Ms. Williams: With psychiatry it is similar to what I learned in the late 1980’s, and early 1990's, when the team of people I was working with introduced the PSA blood test; at the time an unknown blood test. The clinicians were interested and considered how they would use it. Some said they did not need a blood test to diagnose prostate cancer, they do it every day. Others found it very promising. Shortly, the test was being used widely and became a standard of care. Overall, the response to MDDScore with psychiatrists has been positive and other specialties such as Ob/Gyn and physicians managing patients with chronic pain are receptive. We are in the beginning stages of making MDDScore available to these medical specialties. In the future we will prepare to make it widely available to primary care physicians. As you know we are a small company and do not have the current resources to penetrate the primary care market. We will be looking at partnerships to assist us.
CEOCFO: What is the difference between a four and a five? How can a four be ‘no’ and a five be ‘yes’? Where are you in that grey area? Ms. Williams: The result or the score is the likelihood that a patient has Major Depressive Disorder. MDDScore is similar to other blood tests which are used as an aid in diagnosing a disease or disorder. Therefore, we suggest that MDDScore be used in conjunction with other clinical factors. Then it comes to the overall statistics; the large number of patients that we tested, and the way the algorithm works, gives us the confidence in the data that suggests a low likelihood of MDD if a patient has a score of four or less, and a high MDD likelihood if the score is five or higher. Therefore, the physician’s clinical assessment still needs to be factored in. If a patient score is on the high or low end of the scale it is pretty clear. That intermediate area is not a factor in test interpretation and is one with which doctors work very well. The patient seems to be the person that benefits the most from this blood test from the standpoint that once the patient sees a blood test result it doesn’t matter if it is a six, a nine or a five, it suddenly validates their condition; it turns it into a medical condition. Patients become more receptive to the fact that they have this disorder, that it is a disease like any other, that they should stay on their medication and follow their doctors prescribed treatment plan. It allows the doctor to open up a dialog which they may not have had the opportunity to do before. Again, whether it is a five or a four, the interpretation of the likelihood that a person has this disorder helps them -with the appropriate treatment program. Perhaps the doctor will increase the dose of medication or change the medication. Maybe the drugs will not work for them; maybe they are having symptoms that are stimulated from some external condition that counseling may help. This is what we are learning from the doctors that are using MDDScore now. Fifty percent of the first prescriptions of antidepressants fail. Fifty percent is a high failure rate. If the patient is not responding to the drug a look at the blood test may help physicians understand which direction they should take a patient's treatment. This is a way to significantly minimize the ‘trial and error’ process often associated with the diagnosis and treatment of mental health disorders.
CEOCFO: Where is the test actually done? Ms. Williams: The testing is a standard blood draw and we are using standard laboratory equipment. We do all of the testing in our CLIA approved laboratory in Research Triangle Park, North Carolina. Ridge has done most of the research and development and clinical study testing in that laboratory. Today, the patient’s blood is drawn at typical blood draw centers and then sent to our laboratory. Ridge’s laboratory does all of the testing and the analysis and sends the report back to the doctor.
CEOCFO: Is reimbursement a factor? Ms. Williams: Reimbursement is always a consideration for any new medical device or diagnostic test. We do receive reimbursement. Ridge does have coverage by some major payers as well as by Medicare. We are continually working to provide value. We believe that this test is going to take a significant amount of cost out of the system. The large numbers of patients who suffer from this disorder are high utilizers of medical care. In fact, just to give you a few statistics, we are looking at over seven percent of the population of the United States. That is more than those who have cancer or aids. It is about the same amount of people who have cardiovascular disease. Singly, depression is one of ten of America’s most costly diseases and the largest cost of disability worldwide. The numbers are staggering. Healthcare plans are just as affected by the ‘trial and error’ treatment process as the physicians. We think that providing objective diagnostic information will be the first step to help drive the healthcare cost curve down and placing patients in a position to get better quicker.
CEOCFO: What are the next steps for Ridge Diagnostics? In six months, a year? What is the plan? Ms. Williams: Ridge is moving forward with the commercialization of MDDScore. Also, we are planning a product pipeline. Our next blood test is one to evaluate the early efficacy of antidepressant therapy. That is a key area of concern for physicians. Antidepressants are the second most prescribed drug class in the United States. Understanding if a particular drug is going to work early on in the course of a patient’s treatment is very important to physicians. Also, we are looking at bipolar disorder. The company’s plan is to continue to grow organically by executing on our research and commercialization plans.
CEOCFO: What do you see ahead in terms of funding requirements and the ways to meet them? Ms. Williams: Ridge is in the process of closing a financial round which will continue to support MDDScore commercial efforts. Moving forward we are looking to seek financing for further research and development. That may or may not be through strategic partners. We are evaluating potential opportunities.
CEOCFO: Why does Ridge Diagnostics stand out for investors and the business community? Ms. Williams: Ridge Diagnostics stands out because it is the first and the leader in commercializing a blood test in the area of neuropsychiatric disorders. Most healthcare providers will recognize the significance of the size of population that we address both in the incidence as well as in the overall cost associated with diagnosing and caring for those individuals. Mental illness is an extraordinarily large global market opportunity. It affects teenagers and adults. It is a diagnosis of the young to the point where it is the leading cause of medical disability for people age fourteen to forty-four; people working and at the height of their lives. Therefore, the impact MDDScore can have on the population is significant. Where we stand out is that we are the first to create an objective diagnostic blood test tool for mental disorder. I believe strategic partners will be excited about the promise and the market potential of this diagnostic. We have had many conversations where pharmaceutical companies are interested in further understanding how this may help with their clinical studies, and secondly potentially show improved efficacy of their drugs; because those patients who have a clear diagnosis have a higher propensity to respond to a drug. Additionally, we have had many conversations with pharmaceutical companies exploring how Ridge might develop a blood test to help monitor the efficacy of a particular drug.
Ridge is
at an exciting juncture in
the
company’s
history. We are
well poised to address the new era of personalized medicine with added
benefits of improving patients’
neuropsychiatric treatment plans
and
offering
potential cost savings to the healthcare system. Our focus is on assisting
the clinical community with achieving positive patient outcomes. |
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Interview
conducted by: Lynn Fosse, Senior Editor